FDA trying to regulate supplements- Contact House Representative

[Guest guest]

As stated below the US Supreme Court has refused to stop FDA from removing a

supplement if at ANY dose it can cause harm. Together with the Senate bill

S.1082, authorizing FDA to monitor food and 'food ingredient safety' it is

possible for FDA to try to remove a supplement (regulated as a food) if it is

dangerous at any dose. This was the case of Ephedra, being appealed. Our effort

to contact the House and Representative Fran Pallone, Chairman of the Health

Subcommittee of the Energy & Commerce Committee to drop this language

allowing FDA to regulate food and food ingredients has been eliminated from the

House bill due to our efforts. Keep contacting your representative and thank

Chairman Pallone for taking out the language allowing FDA to regulate foods

and

ask him to keep it out of the bill.

arnold

IAHF List:

This just in from Byron Richards- Please read it carefully to have the solid

understanding you'll need in the weeks ahead as we strive to communicate our

urgent message to legislators that we must have an amendment to S.1082/HR

1561. Please read this through a couple of times so whats happening really

sinks in.

 

This article is posting on NewsWithViews tonight. It is Part 1 of 2, The

Emord amendment and whatever strategy we come up with can post in a few days.

This needed to get out right away due to the timeliness of the Supreme Court

decision.

 

Permission to reprint.

 

Understanding the Threat to Dietary Supplements - Part 1

The FDA is Acquiring New Powers to Suppress Alternative Health

Byron Richards, CCN

May 15, 2007

NewsWithViews.com

Your right to have free access to safe and highly effective dietary

supplements is under an intense multi-pronged FDA attack. On May 14, 2007 the

Supreme

Court sided with the FDA by deciding not to hear the case of Nutraceutical v

FDA, letting stand a federal appeals court ruling that permits the FDA to

use drug-related risk/benefit analysis to determine if a nutrient is safe.

This is the exact same point the FDA is trying to get put into law through

Senate bill S.1082 and HR.1561, which consumers have flooded the Senate on

over the past few weeks. And it is the same point the FDA is seeking to help

implement on an international basis through Codex. The Supreme Court denial to

hear this case is a dramatic turn of events that means there is very little

time left to act to preserve free access to dietary supplements. The first

part of this article explains this issue in depth so that Americans can

understand what is taking place. The second part (to come soon) explains the

steps Americans need to take to preserve their health freedom.

Leading health freedom attorney, Jonathan Emord, has been handling the

Supreme Court petition for Nutraceutical Corporation. He has also been helping

us

prepare amendments to neutralize the threat posed by current FDA reform

legislation (S.1082/HR.1561). On May 11, 2007 I received an email from Mr.

Emord

explaining the significance of the Supreme Court case:

“In particular, FDA for the first time in its history now holds a dietary

ingredient or dietary supplement adulterated at every dose level if at some

dose level it can be shown to present even an infinitesimal risk if it

concludes

there to be no substantial health benefit from the supplement. Because all

dietary ingredients, dietary supplements, and foods present a risk to health

at some level of ingestion, the FDA’s new position permits the agency to

declare any dietary ingredient or dietary supplement adulterated at its whim or

caprice.â€

This abhorrent FDA strategy is now the prevailing legal precedent in the

land. The FDA has also launched a sneak attack on dietary supplements through

Senate bill S1082, seeking to slip wording into the bill that would allow this

exact strategy to become law. Language within the bill allows the FDA to use

drug-related risk assessment to brand dietary supplements as unsafe,

overturning fundamental principles of food and drug law.

Under current law, it is up to the FDA to show that a food, food ingredient,

or dietary supplement is adulterated and poses a risk to human health. The

FDA is seeking to redefine the term “adulterated.†Please take the time to

read and understand the substance of these issues – the future of health

freedom in America depends on enough people understanding what is at stake.

Within 1-2 weeks the House is likely to take up the same legislation that the

Senate recently passed (S.1082). We must be ready to take action.

Basic Food Adulteration

It is rather easy to understand that a food or food ingredient that is

contaminated by bacteria, parasites, fungal toxins, lead, or other chemicals

may

pose a risk to human health and therefore be adulterated. One example is the

infectious E. coli that caused the recall of spinach last summer.

Industries constantly lobby the EPA and the FDA to ensure that various

levels of chemicals, whether used as pesticides (like organophosphate nerve

toxins) or found in the water (like perchlorate or PCBs) will be acceptable at

certain levels in the food supply. Natural health advocates argue that not

only

are many of the government-sanctioned levels of toxins acutely detrimental to

health, but the bio-accumulation of these poisons over the course of a

lifetime is a primary cause of obesity, cancer, and heart disease.

Government regulatory agencies invariably side with the profits of industry,

and when they don’t industry files ridiculous law suits that tie issues up

in court forever – all at the expense of human health. More insidiously, the

FDA even acts to promote adulteration of food to support the economic

priorities of the White House and its industry friends, as is the case with

genetically modified crops wherein a toxin is now in every single cell of the

genetically altered food.

It is FDA management’s opinion, whose employees are a revolving door with

the industries they regulate, that such toxins in food are safe. The FDA

shocked many people last fall when they approved an industry-favorable cocktail

of live viruses be added to the food supply. Thus, the EPA and the FDA do a

poor job of establishing criteria for and managing even obvious adulteration

of food and food ingredients, a problem that has been part of FDA culture

since its inception 100 years ago.

On an international basis, the FDA-supported Codex Alimentarius is seeking

to set international standards for food adulteration so low, including the

elimination of true organic standards, that many contaminants that are adverse

to health (such as the level of mycotoxin allowed in food) will be sanctioned

as legal for the purpose of international trade. While Codex is a United

Nations group, the members concocting these international guidelines are

typically responding to the wishes and financial interests of multi-national

corporations.

Adulteration of Food Itself

Another aspect of adulteration is the food or dietary supplement ingredient

itself, as different from some type of contamination. For example, certain

mushrooms are poisonous in small amounts and are thus unsafe. In general,

food and food ingredients are considered safe unless proven otherwise. Indeed,

courts in the United States have recognized time and again that food and food

ingredients are inherently safe. Under current law it is up to the FDA to

prove that a specific ingredient poses a risk, based on a preponderance of

evidence – not based on FDA opinion. This is much different than drug safety

law, wherein the drug company must prove that the benefit of a drug, which is

inherently toxic, outweighs the risk.

The recent Supreme Court case involves the herb Ephedra, wherein a high dose

may have adverse cardiovascular side effects. However, there is no evidence

that lower doses cause any harm at all. The herb has been in traditional

use for several thousand years. The FDA has no proof that it poses any harm

whatsoever in smaller amounts. By using drug-related risk/benefit analysis

the FDA stated it had the authority to remove Ephedra at any dose – thus

overturning basic fundamentals of food and drug law. As long as this case

stands

the FDA has the legal precedent to do this with any herb or vitamin it

chooses.

The FDA’s next step is to make this type of risk analysis into actual law.

The language in S1082 is cleverly worded so that food and food ingredients

(and thus dietary supplements) are lumped into the same category as drugs for

safety review purposes. The FDA is slyly seeking to change existing law so

that if the FDA determines even a small risk in any dietary supplement

ingredient it can brand the ingredient as unsafe, even if the commonly consumed

dose

poses no threat to safety at all.

Let’s take water as an example. We now know that too much water can kill

athletes or those in military training when consumed at an amount greater than

1 ¼ gallons over a two hour period. Under the new wording in S1082, if the

FDA, IN ITS OPINION, decided that the benefits of water were not adequate to

warrant this risk, it could remove water from the market (even a sip of

water). This is based on drug-related risk/benefit analysis. While it is

unlikely

FDA would ever try to remove water from the market, this same ludicrous

logic can be applied to any dietary supplement ingredient – thus gutting the

law

known as DSHEA that gives Americans access to natural health options.

In recent days many Americans flooded the Senate with objections to this

language and a proposed amendment to correct the problem, which Senator Enzi

refused to place into the bill. Some progress was made in that Senators Hatch,

Harkin, Kennedy, and Enzi went on record insisting that bill S1082 will not

affect dietary supplements or alter DSHEA (Dietary Supplement Health and

Education Act of 1994). However, the problematic language remains in the

version

of the legislation passed by the Senate. The battle now moves to the House.

If this language becomes law the FDA will gain new regulatory power to

remove dietary supplements based on highly-opinionated risk assessment

(toxicology) criteria. It has long been a goal of the FDA to have dietary

supplements

regulated as drugs, against the wishes of the great majority of Americans.

The Critical Path Initiative and the Reagan-Udall Foundation for the FDA

The FDA would implement this draconian dietary supplement strategy using

highly advanced technology being developed by the Critical Path Initiative. In

order to fully understand the threat to dietary supplements it is necessary

to understand this approach. The Critical Path Initiative is the FDA’s

attempt

to invigorate the sagging pharmaceutical industry. Its purpose is to

modernize drug development and bring new drugs to the market with less cost and

significantly less testing for safety or effectiveness. The Critical Path

Initiative utilizes cutting edge science relating to genes (genomics), proteins

(proteomics), and cells.

The technology is on the one hand exciting, as well as unproven and very

risky. The Critical Path Initiative is being driven by multiple forces (Wall

Street, the next wave of drugs, and the dream of treating untreatable

diseases). The FDA is gambling that the Critical Path Initiative is the

future. FDA

Commissioner Andrew von Eschenbach, M.D. has stated that this initiative is

the top priority of the FDA for many years to come. The recently promoted

second in command at the FDA, Janet Woodcock, has focused on the Critical Path

Initiative from its inception several years ago.

From a practical standpoint of drug safety today, wherein several million

Americans are injured each year requiring medical attention and over 100,000

Americans die from drug errors and side effects, the Critical Path Initiative

is a pie-in-the-sky pipe dream. Proponents of it promise to solve these

existing drug safety issues by turning the practice of medicine over to FDA

computers.

The goal of the FDA is to use the Critical Path Initiative to radically

change the drug approval and monitoring process from one based on extensive

human

clinical trials to one based on biomarkers. A biomarker is like a

signpost. Some biomarkers indicate toxicity (risk assessment and analysis

technology) and other biomarkers indicate a positive change in a cell or a

defined

clinical event (like tumor shrinkage). The FDA has undertaken a massive

campaign, including the development of its own software, to analyze biomarkers

and

set up standards for drug development and disease treatment.

This means that the current safety and effectiveness testing based on

rigorous clinical trials will be replaced. It also means that a physician’s

clinical judgment will be of secondary importance compared to FDA

supercomputers

(doctors will soon be lining up to join the health freedom movement). Simply

because a biomarker looks good in a computer does not mean that a positive

change is being produced or will be produced in the individual – especially

in

the long term. The focus of drug development will shift to drugs that target

biomarkers as compared to drugs that demonstrate they improve human health.

 

Many cellular proteins and protein-related pathways play both a positive and

negative role in cell chemistry – depending on what the cell is trying to

do. Thus, using risk assessment for biomarkers is incredibly complex and

fraught with potential error – simply because we are still in our infancy of

knowledge in terms of understanding how signaling pathways in cells work. The

net

result is that new and powerful biological drugs will come to the market

faster with much less human testing for safety or effectiveness, and then the

FDA will monitor the drugs as they are being used by patients and try to figure

out if they are safe or not. Both Kennedy and Von Eschenbach make wild

claims that this unproven technology will help drug safety, which at this time

is

nothing but unsubstantiated propaganda.

Under the Clinical Path Initiative patients entering the doctor’s office for

the “best possible care†will instead receive the latest FDA/Big Pharma

drug experiment with extremely expensive biotech drugs. As Von Eschenbach

stated on May 1, 2007 patients should be happy about this because this new

science

will “explore the unique genetic and biologic features of individuals that

will determine how he or she responds to treatment.†Translated to English

that means your DNA will not only be profiled, it will be in a

government-controlled supercomputer in order for you to receive medical care.

The purpose for creating the Reagan-Udall Foundation for the FDA in bill

S1082 is to facilitate a collaboration between Big Pharma, Big Biotech,

academic

research, and the FDA to get the funding for and carry out the extensive

research required to move the Critical Path Initiative forward. The foundation

will be under the direction of the FDA and will hold patents and licenses

relating to the drugs or devices that are developed. This concept is being

patterned after a smaller Critical Path operation known as C-Path, wherein the

FDA works with Big Pharma to develop drugs.

FDA Commissioner Andrew von Eschenbach has been heavily and financially

involved with Big Biotech companies for many years (leading the elder President

Bush’s C-Change). It is no secret that the FDA is now headed by a biotech

representative who has a top priority of bringing drugs to the market faster

and a documented history of conflicts of interest. No person in the civilized

world should be duped into thinking this means improved safety.

Von Eschenbach will argue that the cost and complexity of developing the

next generation of drugs and standardizing the drug development is far too

costly for any one drug company – which is true. This is the main reason Von

Eschenbach took the top job at the FDA, to push the Big Biotech plan known as

Critical Path (not because his passion or experience is in food or drug

safety).

One main problem with the Critical Path Initiative is that the FDA becomes

a drug company with an important stake in the success of the drugs it

approves and licensees for use. This creates major conflicts of interest in

multiple ways, with true safety and effectiveness left as large question

marks.

If this is what Americans want in the name of progress then that should have

been what Senators openly debated and voted on. This could have lead to

truly adequate safeguards being built into the law. Senators spent no time at

all debating the Reagan-Udall Foundation for the FDA and its major safety and

discrimination implications. Instead, this part of S1082 was rubberstamped.

It is quite likely that 90% of the Senators do not understand what I have

just explained. It doesn’t take a crystal ball to realize that Senators’

ignorance is likely to result in increased injuries and deaths and will

eventually require the “Biomarker Fraud Act of 2012.â€

Never Underestimate the FDA’s Desire to Attack Natural Health

A great concern is that language written into S1082 gives FDA new regulatory

power that can be used to attack dietary supplements. The problematic

language in S1082 occurs in Subtitle B – The Reagan-Udall Foundation for the

Food

and Drug Administration, as follows:

`(b) Purpose of Foundation- The purpose of the Foundation is to advance the

mission of the Food and Drug Administration to modernize medical, veterinary,

food, food ingredient, and cosmetic product development, accelerate

innovation, and enhance product safety.

`© Duties of the Foundation- The Foundation shall--

`(1) taking into consideration the Critical Path reports and priorities

published by the Food and Drug Administration, identify unmet needs in the

development, manufacture, and evaluation of the safety and effectiveness,

including

postapproval, of devices, including diagnostics, biologics, and drugs, and

the safety of food, food ingredients, and cosmetics;

Earlier versions of S1082 did not contain the food and food ingredient

language, nor does the current companion bill sitting in the House (HR 1561)

–

although now that the Senate has passed S1082 it is likely that the House will

take up the full Senate version and work from there. My point is that

sneaking the words food and food ingredients into this legislation is a recent

change.

In January of 2007 the FDA issued a press release on the Critical Path

Initiative. The FDA now wants to use the Critical Path risk assessment

technology

to help determine adulteration of food and food ingredients, such as

identifying bacterial contamination (a valid use) AS WELL AS ASSESSING THE

SAFETY OF

FOOD AND FOOD INGREDIENTS (a use that can be used to frivolously attack

dietary supplements with drug-based risk/benefit analysis). The FDA is trying

to expand the role of the Critical Path Initiative from a new drug development

initiative into new regulatory tools. The FDA states:

“The Critical Path Initiative is not limited to the sciences that support

human medical product development. Scientific advances hold the potential to

improve the tools FDA uses to evaluate the safety and efficacy of human and

veterinary products as well as the safety and nutrition of food and food

ingredients (e.g., new rapid tests for biological and chemical contamination of

animal-derived foods, technologies for detecting and mitigating the microbial

contamination of food, analysis technologies [i.e., drug based risk/benefit

analysis] for assessing the safety and nutritive value of foods and food

ingredients).â€

Based on the recent additions of “food†and “food ingredients†to the

S1082 legislation and this FDA document it can be seen that FDA wants to use

the

Critical Path Initiative technology to not only look for contamination of

food (a good use) but also to evaluate safety of food and food ingredients. As

I explained in the preceding sections, this technology is based on risk

assessment and analysis (toxicology) using biomarkers and will fall heavily on

FDA

OPINION using drug-related risk/benefit analysis.

There are two very important questions: What biomarkers will be used? and,

How will biomarkers be set up to determine the level that is toxic?

Unfortunately, the answer to the second question is based primarily ON THE

OPINIONS

OF WHOEVER IS SETTING THE STANDARDS, which is in this case the FDA.

For example, let’s say you developed an invention to test the volume level

of a stereo. In this analogy “volume†is a biomarker. You can plainly

test

for various volume levels, ranging from soft to loud. At what level is the

volume a problem? Do we set the level based on shattering ear drums? What

you think is nice? What a neighbor thinks is correct? In others words, the

threshold for a “toxic†volume level is easily influenced by opinion or

government policy – not science.

Now remember, biomarkers are changes in proteins at the cellular level.

Food, food ingredients, and dietary supplements obviously change proteins at

the

cellular level and will thus change a wide variety of biomarkers. Dietary

supplements are indeed powerful changers of biomarkers. In a normal and sane

world, this ability to see what dietary supplements do would be used to help

individuals prevent and treat disease. In the anti-competitive FDA

police-force world this same technology will be used to get competition off the

market. The FDA can set the “volume†knob for health-related biomarkers

based

primarily on opinion and say “we only allow soft music, everything else

requires a prescription.â€

Let’s take a specific example. NF KappaB is a protein that operates within

a cell – in reality it is the brain of a cell that manages cellular stress.

NF KappaB levels go up and down and do various things – all towards the goal

of maintaining healthy cellular function. Many nutrients directly modulate

NF kappaB, which is how they work to help a cell repair itself, reduce

inflammation, and maintain normal healthy function. In almost every type of

cancer,

NF KappaB is hijacked and the cell’s natural defense system is taken over –

like a terrorist attack. In this case, the volume knob on NF KappaB is now

set in such a way that the music sounds like a loud blaring rock station and

the excessive NF KappaB is the actual force driving the cancer process.

Drugs are designed to knock out this hyped-up NF KappaB signal, resulting in

death to cancer cells. The problem is of course that most drugs are not

specific only to cancer cells, and interruption of NF KappaB in healthy cells

also results in healthy cell death. Surviving cancer treatment is often a race

between killing enough cancer cells before killing too many healthy cells.

Along comes green tea. Green tea polyphenols, like many nutrients, change NF

KappaB. Mother Nature has empowered green tea with wisdom that no drug

possesses. Green tea can tell the difference between a cancer cell and a

healthy cell. Green tea will take its best crack at turning off excessive NF

KappaB in a cancer cell and thereby help induce the cancer cell to die.

Amazingly, green tea will not bother the NF KappaB in a healthy cell, other

than to

assist it in normal and healthy cell function. This does not mean that green

tea is a cure for cancer or even a treatment for cancer – but it sure won’t

hurt someone who takes it who has cancer.

It will be easy for the FDA to say, with the new powers proposed in S1082,

that green tea is unsafe because it changes biomarkers related to cancer. The

statement is factual. It is the OPINION of the FDA that the change is a

problem. The language in S1082 gives the FDA the regulatory power to make that

opinion stick, thus setting back natural options for health fifty years.

You may find it hard to believe that the FDA would follow this path when so

many people are in need of natural and safe health options. Yet, the FDA is

already working with Codex on an international basis to help establish risk

analysis (toxicology) for dietary supplements. FDA scientists are heavily

involved with the Codex Committee on Nutrition and Foods for Special Dietary

Uses

(CCNFSDU). In the upcoming meeting in Germany in Nov 2007 an FDA-supported

plan will be presented in an effort to help establish the application of risk

analysis to guide CCNFSDU to set “Safe Upper Limits†for dietary

supplements.

Safe Upper Limits, as currently viewed by Codex, are a public health scam;

they are a politically correct strategy for branding dietary supplements as

drugs based on drug-related risk analysis technology. The FDA and Codex goal

is to remove therapeutically useful dietary supplements from the free market

so they don’t compete with drugs. Another goal is to make all useful

nutrients into prescriptions to give Big Pharma a total monopoly on all health

options.

We must educate our legislators and get them to help us preserve our right

to have free access to helpful dietary supplements. Coming soon – Part 2

(the

take action plan).

Copyright © TruthInWellness, LLC

Related articles:

1, Fight for Your Health: Exposing the FDA’s Betrayal of America (read free

–

documents FDA corruption)

2, Senators Chose Big Pharma over Best Interests of U.S. Citizens 5-9-07

(Key drug safety amendments lose, Big Pharma wins)

3, S1082 – Senate Stabs Americans in the Back 5-7-07 (The Senate shoots down

fair drug pricing for Americans)

4, What is Really Going On at the FDA 5-7-07 (S1082 - explains the user fee

scam and anti-American FDA activities)

5, S1082 - The Voice of the People is Being Heard 5-4-07 (Citizens are

flooding the Senate – Why FDA wants to be a drug company)

6, Senators Bribed by Big Pharma vs. Senators not Bought Off 5-2-07 (S1082 –

Big Pharma vs American Citizens – Senators used as pawns)

7, Dietary Supplements Threatened, Freedom in Danger 4-30-07 (S1082 – How

drug-safety legislation threatens dietary supplements)

8, U.S. Health Freedom on Verge of Collapse 4-25-07 (An overview of S1082

and how it undermines health freedom)

Byron J. Richards, Founder/Director of Wellness Resources, is a

Board-Certified Clinical Nutritionist and nationally-renowned health expert,

radio

personality, and educator. He is the author of Mastering Leptin, The Leptin

Diet,

and Fight for Your Health: Exposing the FDA's Betrayal of America.

You may now read Fight for Your Health free, and/or purchase the book or a

PDF download. All proceeds from the sales go to defend health freedom.

Richards encourages individuals to take charge of their health, stand up for

their health rights, and not blindly succumb to propaganda from the

vested-interests who profit from keeping Americans sick. As founder of Wellness

Resources, Inc. of Minneapolis, MN, an independently-owned fine-quality dietary

supplement company since 1985, he has personally developed 75 unique

nutraceutical-grade nutritional formulas. _www.wellnessresources.com_

(http://www.wellnessresources.com/)

E-mail: _byron_ (byron)

For Health Freedom, John C. Hammell, President International Advocates for

Health Freedom 556 Boundary Bay Road Point Roberts, WA 98281-8702 USA

http://www.iahf.com jham 800-333-2553 N.America 360-945-0352 World

 

 

 

 

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